Breast CancerNCT04962529
Breast Cancer Liquid Biopsy Trial
An observational study of Breast Cancer and Cancer, run by Anthony Magliocco at 8 sites in 2 countries.
Trial summary
The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cancer
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 28 Sep 2020to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study cohort will be selected from the Breast Cancer patients visiting enrolled sites for the treatment of their disease.
Arm 1 Inclusion criteria:
- All subjects must be capable of providing informed consent
- Subjects (≥ 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis. o Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment
- Subjects must have suspected recurrent metastatic BC or MBC with clinical signs of progression that will be confirmed/evaluated by tissue biopsy that is expected to yield tissue adequate for histologic examination. Note that patients presenting with de novo metastasis are eligible provided a tissue biopsy meets the above criteria.
- Tissue biopsy of a suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study.
- The suspected metastases biopsied may be from any lesion outside the ipsilateral breast and axilla, infra/supraclavicular areas.
- In those with suspected metastases in contralateral axilla, infra/supraclavicular areas, only a new contralateral breast primary must be excluded by imaging.
- No history of any other cancers (except for non-melanoma skin cancer)
- Ability to access 3-month outcome data (de-identified, consented patients included for second draw at 3-month timepoint or within 14 days for the first post-treatment imaging, whichever comes first).
- Data from contemporaneous diagnosis (metastatic recurrence or de novo) and in applicable past diagnosis (primary) must be accessible, including a pathology report that details standard markers and morphology describing how malignancy/cancer of origin was determined.
Arm 1 Exclusion Criteria:
- Unable to provide informed consent
- New treatment commences prior to liquid biopsy blood collection
- Previous history of an invasive non-breast cancer (except for non-melanoma skin cancer)
- Subjects not undergoing a tissue biopsy at time of blood draw (for suspected breast cancer recurrence or prior to beginning new line of metastatic treatment)
- Subjects with only a new contralateral breast primary tumor
Arm 2 Inclusion criteria:
- Capable of providing informed consent
- Subjects (≥ 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis.
- Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment
- The suspected metastasis biopsied may be from any lesion outside the ipsilateral breast and axilla, infra/supraclavicular areas.
- In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only, a new contralateral breast primary must be excluded by imaging.
- Confirmation of progression of MBC must be confirmed by imaging
- (Optional) Tissue biopsy of suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study.
- No history of any other cancers (except for non-melanoma skin cancer)
- Data from primary BCa diagnosis must be accessible, including detailed description with standard markers and morphology describing how malignancy/cancer of origin was determined.
- Subject must exhibit clinical signs of breast cancer recurrence or progression of previously confirmed metastatic breast cancer
Arm 2 Exclusion Criteria:
- Subjects unable to provide informed consent
- New treatment regimen commences prior to liquid biopsy blood collection
- Subjects on treatment for MBC with no imaging evidence of clinical progression
- Previous history of an invasive non-BC apart from cancers treated with curative intent at least five (5) years previously with no recurrence since diagnosis, with the exception of a non-melanoma skin cancer
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Laura Lozano, 847-618-4358, llozano@nch.org
Karen Zwicky, MS, 8476184386, kzwicky@nch.org
- Recruiting
Miami Memorial Healthcare System
Hollywood, Florida, 33021
Jayme Ion, jion@mhs.net
Nithya Sundararaman, 9542651846, NSundararaman@mhs.net
- Recruiting
New York Cancer & Blood Specialists
New York, New York, 10028
Laura Brady, lbrady@nycancer.com
Joseph Battelli, jbattelli@nycancer.com
- Recruiting
Ocala Oncology
Ocala, Florida, 34474
Sanjit Nirmandalahan, PhD, 352-547-1958, Sanjit.Nirmalanandhan@usoncology.com
Darcy Benedetto, (352) 547-1905, darcy.benedetto@usoncology.com
- Recruiting
6555 Sanger Rd, Suite 260
Orlando, Florida, 32827
Hannah Park, BS, 754-241-4209, hannah.park@proteanbiodx.com
Joseph M Viscomi, BS, (754) 946-4309, joseph.viscomi@proteanbiodx.com
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Jon-Michael Eckert, 941-917-4797, jon-michael-eckert@smh.com
Russell Novak, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Prena Etchen, pzagreda@montefiore.org
Benjamin Duva, benjamin.duva@einsteinmed.edu
Canada1 site, 1 recruiting
- Recruiting
Saskatoon City Hospital
Saskatoon, Saskatchewan
Rashmi Nagaraj, MSc, rashmi.nagaraj@usask.ca
Andreea Badea, andreea.badea@usask.ca
About this study
Official title: Liquid vs Tissue Biopsy Concordance in Samples of 1st Suspected BCa Recurrence/Metastasis and Evaluation of DefineMBC Comprehensive Cancer Profiling Liquid Biopsy LDT
The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. The knowledge gained in this study could be used in future studies to confirm cancer recurrence using a safe and minimally invasive procedure. The research will consist of looking for tumor cell(s) circulating in the blood stream and if they are present to characterize them so that more information about the disease can be collected. This information may help us to better understand how to fight cancer.
Read the detailed description
An estimated 287,850 women will be diagnosed with invasive breast cancer in the US in 2022 (cancer.org). Most women with breast cancer present with disease confined to the breast and local lymph nodes, where surgical removal of lesions is standard of care and well-managed. Those diagnosed and treated for primary breast cancer often recur with metastatic disease more than 5 years after initial diagnosis. (Pan, NEJM 2017).
Sadly, when lesions emerge in other areas, after months or decades with no evidence of disease, mortality rates rise. The most common sites of distant recurrence of breast cancer are the bone, lung, liver, and brain, (Lin, NCCN 2012), all of which are difficult to biopsy, and obtain pathological evidence of malignancy because metastatic lesions: 1) are not always accessible/deeply located, 2) are prone to under sampling, and 3) may present dense fibrotic tissue. In addition, tissue biopsy methods in metastatic lesions have been shown to:
- have low patient compliance,
- have high discordance rate with malignant lesions at imaging,
- be incompatible with longitudinal monitoring.
As a result, at a critical point in patient care, there is still a current unmet need for diagnostic information to guide decision-making.
As established widely in published literature over the past decade, receptor status often changes between primary and metastatic disease, and during lines of metastatic treatments, changing the trajectory of the disease and further highlighting the need for longitudinal evaluation of receptor status. Occult micro-metastases or minimal residual disease (MRD) cannot be detected with current medical modalities and can originate metastatic relapse at distant sites. For this reason, cellular and molecular liquid biopsy approaches that enable detection of disease relapse allow therapy escalation many months earlier than overt relapse detected by imaging which as result may increase patients' survival. Based on discussions, interviews, and surveys of both thought-leading academics and community-based medical oncologists, there is an evident opportunity to improve patient care. Moreover, the market shows receptivity to a blood-based test for these inaccessible cases as well as improve identification of patients at high risk of relapse or eligible for earlier treatment escalation compared to current tissue biopsy testing in practice today.
In this clinical trial the purpose is to examine the potential of blood draws as a rapid and less invasive alternative to biopsies. Additionally, to compare the results of Epic Sciences' liquid biopsy test, DefineMBC, with results of standard-of-care (SoC) pathology results from metastatic contemporaneous tissue biopsies. With the implementation of our newest Registry Arm of patients, our goal is also to provide participating physician investigators the results Epic Sciences' liquid biopsy test, Define MBC, for breast cancer subjects with no central pathology data and utilize physician feedback for test experience improvements.
- Conditions
- Breast Cancer, Cancer
- Being tested
- Blood Draw
- Keywords
- Recurrence, Metastatic Breast Cancer, Liquid Biopsy, Protean BioDiagnostics, Blood
- Medical subject headings
- Breast Neoplasms, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Metastatic Breast Cancer Patients With Contemporaneous Tissue Biopsy | Investigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram or MRI
If a tissue biopsy is performed, the matched tissue will be sent to the central pathology lab for reanalysis. If a tissue biopsy was performed, but the tissue block is exhausted or unavailable, patients are still eligible to participate in the study. Receives: Procedure: Blood Draw | |
| Arm 2: Metastatic Breast Cancer Patients Without Contemporaneous Tissue Biopsy | Investigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram or MRI.
A contemporaneous tissue biopsy is optional for this cohort. Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between liquid and tissue biopsy in terms of presence or absence of cancer
To analyze concordance between liquid biopsy, Circulating tumor (ct) cells and ctDNA (academic assays based on mutations and/or epigenetic changes), with biopsy results (presence or absence of cancer), and with all blood assays being conducted blinded to tissue biopsy results
Measured: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Secondary outcomes (4)
Classification of tissue biopsy
After confirmation of tumor area and cellularity, slides will be stained with the appropriate Immunohisto Chemistry: Progesterone Receptor (clone 1E2), Estrogen Receptor (clone SP1), GATA3, TTF1, PD-L1 (SP142), FOXA1, or HER2 (4B5).
Measured: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Exploratory analysis
Exploratory analyses will include agreement of GATA3, FOXA1 and PDL1 staining results between liquid and tissue biopsies, where possible.
Measured: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Concordance between liquid and tissue biopsy in terms of hormone and HER2 status
Secondary analysis of the concordance between hormone receptor and HER status identified on tissue with identified CTCs
Measured: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Physician Feedback for Test Experience Improvements
To provide participating physician investigators the results Epic Sciences' liquid biopsy test, Define MBC, for breast cancer subjects with no central pathology data and utilize physician feedback for test experience improvements
Measured: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start28 Sep 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anthony Magliocco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Epic Sciences, DHR Health Institute for Research and Development, Memorial Healthcare System, University of Saskatchewan, Florida Cancer Specialist, Montefiore Medical Center, Ocala Oncology, NY Health d/b/a New York Cancer and Blood Specialists, Northwest Community Healthcare
- Responsible party
- Sponsor-investigator, Anthony Magliocco, Protean BioDiagnostics
- Investigators
- Anthony Magliocco, MD, Principal investigator, CEO and Founder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962529
- Sponsor's protocol ID
- PCS-001
- Status last verified
- Aug 2022
- First submitted
- 17 Dec 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid vs Tissue Biopsy Concordance in Samples of 1st Suspected BCa Recurrence/Metastasis and Evaluation of DefineMBC Comprehensive Cancer Profiling Liquid Biopsy LDT
- ClinicalTrials.gov ID
- NCT04962529
- Acronym / sponsor ID
- PCS-001
- Conditions
- Breast Cancer, Cancer
- Keywords
- Recurrence, Metastatic Breast Cancer, Liquid Biopsy, Protean BioDiagnostics, Blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Anthony MaglioccoIndustry (pharma, biotech, devices)
- Collaborators
- Epic Sciences, DHR Health Institute for Research and Development, Memorial Healthcare System, University of Saskatchewan, Florida Cancer Specialist, Montefiore Medical Center, Ocala Oncology, NY Health d/b/a New York Cancer and Blood Specialists, Northwest Community Healthcare
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. The knowledge gained in this study could be used in future studies to confirm cancer recurrence using a safe and minimally invasive procedure. The research will consist of looking for tumor cell(s) circulating in the blood stream and if they are present to characterize them so that more information about the disease can be collected. This information may help us to better understand how to fight cancer.
Detailed description
An estimated 287,850 women will be diagnosed with invasive breast cancer in the US in 2022 (cancer.org). Most women with breast cancer present with disease confined to the breast and local lymph nodes, where surgical removal of lesions is standard of care and well-managed. Those diagnosed and treated for primary breast cancer often recur with metastatic disease more than 5 years after initial diagnosis. (Pan, NEJM 2017).
Sadly, when lesions emerge in other areas, after months or decades with no evidence of disease, mortality rates rise. The most common sites of distant recurrence of breast cancer are the bone, lung, liver, and brain, (Lin, NCCN 2012), all of which are difficult to biopsy, and obtain pathological evidence of malignancy because metastatic lesions: 1) are not always accessible/deeply located, 2) are prone to under sampling, and 3) may present dense fibrotic tissue. In addition, tissue biopsy methods in metastatic lesions have been shown to:
- have low patient compliance,
- have high discordance rate with malignant lesions at imaging,
- be incompatible with longitudinal monitoring.
As a result, at a critical point in patient care, there is still a current unmet need for diagnostic information to guide decision-making.
As established widely in published literature over the past decade, receptor status often changes between primary and metastatic disease, and during lines of metastatic treatments, changing the trajectory of the disease and further highlighting the need for longitudinal evaluation of receptor status. Occult micro-metastases or minimal residual disease (MRD) cannot be detected with current medical modalities and can originate metastatic relapse at distant sites. For this reason, cellular and molecular liquid biopsy approaches that enable detection of disease relapse allow therapy escalation many months earlier than overt relapse detected by imaging which as result may increase patients' survival. Based on discussions, interviews, and surveys of both thought-leading academics and community-based medical oncologists, there is an evident opportunity to improve patient care. Moreover, the market shows receptivity to a blood-based test for these inaccessible cases as well as improve identification of patients at high risk of relapse or eligible for earlier treatment escalation compared to current tissue biopsy testing in practice today.
In this clinical trial the purpose is to examine the potential of blood draws as a rapid and less invasive alternative to biopsies. Additionally, to compare the results of Epic Sciences' liquid biopsy test, DefineMBC, with results of standard-of-care (SoC) pathology results from metastatic contemporaneous tissue biopsies. With the implementation of our newest Registry Arm of patients, our goal is also to provide participating physician investigators the results Epic Sciences' liquid biopsy test, Define MBC, for breast cancer subjects with no central pathology data and utilize physician feedback for test experience improvements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Metastatic Breast Cancer Patients With Contemporaneous Tissue Biopsy | – | Procedure: Blood DrawInvestigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram or MRI If a tissue biopsy is performed, the matched tissue will be sent to the central pathology lab for reanalysis. If a tissue biopsy was performed, but the tissue block is exhausted or unavailable, patients are still eligible to participate in the study. |
| Arm 2: Metastatic Breast Cancer Patients Without Contemporaneous Tissue Biopsy | – | Procedure: Blood DrawInvestigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram or MRI. A contemporaneous tissue biopsy is optional for this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study cohort will be selected from the Breast Cancer patients visiting enrolled sites for the treatment of their disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawBlood will be drawn from each patient to check the concordance between liquid and tissue biopsy | Procedure or surgery | Arm 1: Metastatic Breast Cancer Patients With Contemporaneous Tissue Biopsy, Arm 2: Metastatic Breast Cancer Patients Without Contemporaneous Tissue Biopsy |
Primary outcome
Concordance between liquid and tissue biopsy in terms of presence or absence of cancer
Time frame: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
To analyze concordance between liquid biopsy, Circulating tumor (ct) cells and ctDNA (academic assays based on mutations and/or epigenetic changes), with biopsy results (presence or absence of cancer), and with all blood assays being conducted blinded to tissue biopsy results
4 secondary outcomes
Classification of tissue biopsy
Time frame: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Exploratory analysis
Time frame: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Concordance between liquid and tissue biopsy in terms of hormone and HER2 status
Time frame: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Physician Feedback for Test Experience Improvements
Time frame: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Company WebsiteLink provided by the sponsor.
- Company Website EnrollmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Magliocco, MD principal investigator
CEO and Founder
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cancer, run by Anthony Magliocco at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Park, BS ((754) 241-4209, hannah.park@proteanbiodx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between liquid and tissue biopsy in terms of presence or absence of cancer (time frame: Time Frame: It is a single visit study and the study investigators would prefer to have the blood draw from patients before tissue biopsy or within 7-28 days of tissue biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.